FDA.reportPublic FDA data

Zantac 360

Product NDC
41167-0361
11-digit product format
411670361
Labeler code
41167
Product ID
41167-0361_efcd0b2f-86c9-43c6-889f-7962e191a9cb
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2021-04-12
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zantac 360
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047, 310273, 2607015, 2609246

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0361-0Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-0Zantac 3608 in 1 BLISTER PACKTABLET, FILM COATED86
41167-0361-1Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-1Zantac 3601 in 1 BLISTER PACKTABLET, FILM COATED16
41167-0361-2Zantac 36025 in 1 BOTTLETABLET, FILM COATED256
41167-0361-2Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-4Zantac 36050 in 1 BOTTLETABLET, FILM COATED506
41167-0361-4Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-6Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-6Zantac 36090 in 1 BOTTLETABLET, FILM COATED906
41167-0361-8Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-8Zantac 360100 in 1 BOTTLETABLET, FILM COATED1006
41167-0361-9Zantac 36070 in 1 BOTTLETABLET, FILM COATED706
41167-0361-9Zantac 3602 in 1 CELLO PACKTABLET, FILM COATED26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0361-0EA - Each41167-0361b6b6fdf4-35ac-4a9a-b9df-a448e8fb2c6d12021-08-05
41167-0361-2EA - Each41167-0361dd5ca820-cc72-4c18-bc29-c5073e60176212021-08-05
41167-0361-4EA - Each41167-0361e31d00a7-f13f-472c-a6a7-5d6b637c5e0112021-08-05
41167-0361-6EA - Each41167-03618ea2a35a-13dd-47d5-ae86-7189362d87d112021-08-05
41167-0361-8EA - Each41167-0361d82c8712-128d-4bd3-afbb-92ea11ad6ccf12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0361ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]6Current NDC, Legacy NDC, 14 package rows20250508_89f60eb1-359b-40e8-ae8b-65aec9cd5b1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
310273famotidine 20 MG Oral TabletPSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022PSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015famotidine 10 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
199047famotidine 10 MG Oral TabletSCD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
310273famotidine 20 MG Oral TabletSCD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022SY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac Reformulated Aug 2022 10 MG Oral TabletSY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
310273famotidine 20 MG Oral TabletPSNe328c59c-baed-0e4e-e053-2995a90ab85c2
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSNe328c59c-baed-0e4e-e053-2995a90ab85c2
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBDe328c59c-baed-0e4e-e053-2995a90ab85c2
310273famotidine 20 MG Oral TabletSCDe328c59c-baed-0e4e-e053-2995a90ab85c2
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SYe328c59c-baed-0e4e-e053-2995a90ab85c2
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSYe328c59c-baed-0e4e-e053-2995a90ab85c2
310273famotidine 20 MG Oral TabletPSNb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
310273famotidine 20 MG Oral TabletPSNfd61a2d6-5c8a-4e7a-8b19-37406b90f7781
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSNfd61a2d6-5c8a-4e7a-8b19-37406b90f7781
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSNb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBDfd61a2d6-5c8a-4e7a-8b19-37406b90f7781
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBDb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
310273famotidine 20 MG Oral TabletSCDfd61a2d6-5c8a-4e7a-8b19-37406b90f7781
310273famotidine 20 MG Oral TabletSCDb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SYfd61a2d6-5c8a-4e7a-8b19-37406b90f7781
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SYb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSYb55d4a6d-e2f0-490b-9ca2-caa7eb998eec1
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSYfd61a2d6-5c8a-4e7a-8b19-37406b90f7781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0361-0411670361001 BLISTER PACK in 1 CARTON (41167-0361-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-04-120000-00-00NoNoCurrent
41167-0361-1411670361011 BLISTER PACK in 1 CARTON (41167-0361-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-04-120000-00-00NoNoCurrent
41167-0361-2411670361021 BOTTLE in 1 CARTON (41167-0361-2) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent
41167-0361-4411670361041 BOTTLE in 1 CARTON (41167-0361-4) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent
41167-0361-6411670361061 BOTTLE in 1 CARTON (41167-0361-6) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent
41167-0361-8411670361081 BOTTLE in 1 CARTON (41167-0361-8) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent
41167-0361-9411670361092 BOTTLE in 1 CELLO PACK (41167-0361-9) / 70 TABLET, FILM COATED in 1 BOTTLE2 bottle2021-04-120000-00-00NoNoCurrent